Overweight and ObesityPhase 1NCT07724431
A Phase 1, Double-blind, Randomized Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Dose and Multiple Doses of CG-0416 in Healthy Participants.
A Phase 1 study testing CG-0416 in people with Overweight and Obesity, run by HongKong Curegene Innovation Co., Limited at 1 site in Australia.
Trial summary
A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- CG-0416
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants aged 18 to 60 years, inclusive, at the time of screening.
- BMI of ≥ 18 kg/m2 to ≤ 32 kg/m2 for SAD and ≥ 21 kg/m2 to ≤ 35 kg/m2 for MAD at screening, and body weight > 50 kg for SAD and MAD.
- Participants will be assessed to be in good health by the investigator, such as no clinically relevant abnormalities that will affect participant safety in the opinion of the investigator based on medical history, physical examination, clinical laboratory assessments (hematology, serum chemistry, coagulation, urinalysis, TH), and 12-lead ECG.
- LDL-C > 1.8 mmol/L (70 mg/dL) in SAD, LDL-C > 2.6 mmol/L (100 mg/dL) in MAD.
- Self-reported stable weight (within ± 5% change) for at least 3 months prior to screening.
- Participant and his/her sexual partner are not planning to fall pregnant and male participants can't donate sperm for 95 days after the last dose of study drug and willing to use two or more effective contraception methods (contraception guidance is provided in Appendix 17.1). Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. In addition, females under the age of 55 years must have a documented serum FSH level > 40 mIU/mL to confirm menopause. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level.
- Participants have a full understanding of the trial content, process and possible adverse reactions, and voluntarily signed the informed consent form (ICF).
Who cannot join
- Clinically significant infection and/or cardiovascular, hematologic, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, current or history of ADHD, anxiety or depression, or psychiatric disease at screening that, or its treatment, may have interfered with the conduct of the study (e.g., study procedure compliance, safety assessment, study results interpretation) or, in the judgment of the investigator, will have placed the participant at an unacceptable risk if participating in the study.
- Clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric or cardiovascular disease) within 6 months before screening.
- Thyroid diseases: a) active hyperthyroidism; b) TSH >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
- Diagnosis of type 1 or 2 diabetes or other autoimmune diabetes (fully resolved gestational diabetes will be permitted).
- Glycated hemoglobin (HbA1c) > 6.5% or fasting blood glucose ≥ 7.0 mmol/L.
- Fasting (TG ≥ 500 mg/dL (or 5.65 mmol/L) at screening.
Show all 31Show fewer
- Participant meets any of the following:
- Transaminases (AST, ALT) > 1.5 × ULN.
- Alkaline phosphatase (ALP) > 1.5 × ULN.
- Serum total bilirubin > 1.5 × ULN (participants diagnosed with Gilbert's syndrome at screening are allowed to meet all other criteria).
- Platelet count < 100,000/mm³.
- International normalized ratio (INR) > ULN (as per the local laboratory reference range).
- Albumin < 35 g/L.
- Estimated glomerular filtration rate < 60 mL/min/1.73m2 per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula.
- Severe allergic diseases or suspected allergy to any component of the study drug, allergic constitution (multiple drug and food allergy) judged by the investigator.
- Any of the following abnormalities on the 12-lead ECG at screening:
- QTcF (Fridericia-corrected QT interval) > 450 msec for males or > 470 msec for females.
- In addition to the above, any clinically significant ECG abnormality, as judged by the investigator.
- Systolic blood pressure > 145 mmHg and diastolic blood pressure > 95 mmHg in supine position (at least 5 minutes) at screening, confirmed by retest.
- Use of antibiotics or immunosuppressive drugs (e.g., systemic corticosteroids) within 30 days prior to administration of CG-0416 on Day 1.
- Any short-term or long-term treatment for obesity within 3 months prior to screening.
- For use of prescription medication, within 14 days or 5 half-lives (whichever is longer) before screening with the exception of hormone replacement and contraception therapy. For use of over-the-counter (OTC) medications, food supplements (excluding routing vitamins, paracetamol, ibuprofen), weight loss and fat reduction supplements (L-carnitine, green coffee extract, chitosan, weight loss tea, yerba mate tea, meal replacement, etc.), supplements for thyroid endocrine disruption (iodine supplements, seaweed and kelp extracts, etc.), lipid-lowering supplements (fish oil, etc.) etc. 7 days before screening is sufficient (Only vitamins and other supplements that do not affect the study drug are allowed to be used. Other supplements are not permitted).
- Smoking > 5 cigarettes (or equivalent amount of nicotine products) per week within 30 days before the screening or inability to abstain from tobacco products during the study.
- Any vaccination within 14 days prior to screening or anticipated administration of a live vaccine during the study.
- Receipt of an investigational drug or device or participation in a drug study within 60 days (or 5 half-lives of the drug, whichever is longer) before dosing on Day 1.
- Positive during screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (amplification test to confirm if positive; cured hepatitis C can be enrolled), or human immunodeficiency virus (HIV) antibody, treponema pallidum antibody.
- History of drug abuse within 6 months before screening, or positive drug abuse test at screening.
- Weekly alcohol consumption of more than 10 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of spirit with the alcohol content of 40% or 150 mL of wine) in any week within the past 3 months before screening; intake of alcohol-containing products within 48 hours prior to the first dose of study drug or inability to abstain from any alcohol during the study, or positive alcohol test at screening.
- Donation of more than 400 mL of blood or plasma within 30 days before screening or planned donation within 90 days of study treatment administration.
- Consumption/consumption of coffee, tea, grapefruit, chocolate or soft drinks such as cola containing methylxanthines (theophylline, caffeine or theobromine) within 48 hours before dosing.
- Strenuous exercise, such as weightlifting, sprinting, long-distance running, cycling, swimming, and playing soccer, is performed within 72 hours before screening and any study visit until the follow-up has been completed; if it is not within the window period before the above-mentioned screening and study visits, maintenance of daily exercise or activity plan is allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004
Philip Ryan, MD, 61-0385939801, p.ryan@nucleusnetwork.com.au
Jerneen Williams, 61-0883613222, bellberry@bellberry.com.au
About this study
A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.
- Conditions
- Overweight and Obesity
- Being tested
- CG-0416
- Keywords
- weight loss, CG-0416, Curegene, Obesity, MASH
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-0416Drug
CG-0416 is a novel selective, liver-directed thyroid hormone receptor beta (THR-β) agonist, given orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo Receives: Drug: CG-0416 |
| Cohort 2 | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo Receives: Drug: CG-0416 |
| Cohort 3 | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo Receives: Drug: CG-0416 |
| Cohort 4 | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo Receives: Drug: CG-0416 |
| Cohort 5 | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo Receives: Drug: CG-0416 |
| Cohort 1a | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a low dose of CG-0416 or placebo once daily for 14 consecutive days. Receives: Drug: CG-0416 |
| Cohort 2a | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a middle dose of CG-0416 or placebo once daily for 14 consecutive days. Receives: Drug: CG-0416 |
| Cohort 3a | Experimental | 8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a high dose of CG-0416 or placebo once daily for 14 consecutive days. Receives: Drug: CG-0416 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine number of participants with treatment-related adverse events as assessed by CTCAE v6.0 of single dose and multiple doses of CG-0416 in healthy participants.
Number of Incidence and frequency of adverse events (AEs) / SAEs possibly or probably related to study drug.
Measured: up to 3 weeks
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants
Concentration changes from baseline in clinical laboratory safety tests: thyroid hormones [TH] , thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4)], follicle-stimulating hormone (FSH), luteinizing hormone, estradiol, testosterone, and free testosterone.
Measured: up to 3 weeks
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants.
Baseline and placebo-corrected QTcF (ΔΔQTcF).
Measured: up to 3 weeks
Secondary outcomes (8)
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last).
Measured: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to theoretical infinity (AUC0-inf).
Measured: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
peak concentration (Cmax).
Measured: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time to peak concentration (Tmax).
Measured: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Terminal elimination half-life (T1/2).
Measured: Up to 3 weeks
To assess pharmacodynamic (PD) parameters
Concentration changes from baseline in fasting blood apolipoprotein B (ApoB), lipoprotein (a) [Lp(a)], low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG)
Measured: up to 3 weeks
To assess pharmacodynamic (PD) parameter insulin
Concentration changes from baseline in insulin
Measured: up to 3 weeks
To assess pharmacodynamic (PD) parameter sex hormone binding globulin (SHBG)
Concentration changes from baseline in sex hormone binding globulin (SHBG).
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 will be a single ascending dose (SAD) design, progressing from lowest dose group to highest dose group. Part 2 will be a multiple ascending dose (MAD) design, given orally once daily for 14 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HongKong Curegene Innovation Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Ryan, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724431
- Sponsor's protocol ID
- CG-AU-0416-01
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Dose and Multiple Doses of CG-0416 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07724431
- Acronym / sponsor ID
- CG-AU-0416-01
- Conditions
- Overweight and Obesity
- Keywords
- weight loss, CG-0416, Curegene, Obesity, MASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- HongKong Curegene Innovation Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Part 1 will be a single ascending dose (SAD) design, progressing from lowest dose group to highest dose group. Part 2 will be a multiple ascending dose (MAD) design, given orally once daily for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo |
| Cohort 2 | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo |
| Cohort 3 | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo |
| Cohort 4 | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo |
| Cohort 5 | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo |
| Cohort 1a | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a low dose of CG-0416 or placebo once daily for 14 consecutive days. |
| Cohort 2a | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a middle dose of CG-0416 or placebo once daily for 14 consecutive days. |
| Cohort 3a | Experimental | Drug: CG-04168 healthy participants will be randomly assigned in a ratio of 3:1 to receive a high dose of CG-0416 or placebo once daily for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female participants aged 18 to 60 years, inclusive, at the time of screening.
- BMI of ≥ 18 kg/m2 to ≤ 32 kg/m2 for SAD and ≥ 21 kg/m2 to ≤ 35 kg/m2 for MAD at screening, and body weight > 50 kg for SAD and MAD.
- Participants will be assessed to be in good health by the investigator, such as no clinically relevant abnormalities that will affect participant safety in the opinion of the investigator based on medical history, physical examination, clinical laboratory assessments (hematology, serum chemistry, coagulation, urinalysis, TH), and 12-lead ECG.
- LDL-C > 1.8 mmol/L (70 mg/dL) in SAD, LDL-C > 2.6 mmol/L (100 mg/dL) in MAD.
- Self-reported stable weight (within ± 5% change) for at least 3 months prior to screening.
Key exclusion criteria (31 listed)
- Clinically significant infection and/or cardiovascular, hematologic, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, current or history of ADHD, anxiety or depression, or psychiatric disease at screening that, or its treatment, may have interfered with the conduct of the study (e.g., study procedure compliance, safety assessment, study results interpretation) or, in the judgment of the investigator, will have placed the participant at an unacceptable risk if participating in the study.
- Clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric or cardiovascular disease) within 6 months before screening.
- Thyroid diseases: a) active hyperthyroidism; b) TSH >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
- Diagnosis of type 1 or 2 diabetes or other autoimmune diabetes (fully resolved gestational diabetes will be permitted).
- Glycated hemoglobin (HbA1c) > 6.5% or fasting blood glucose ≥ 7.0 mmol/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-0416CG-0416 is a novel selective, liver-directed thyroid hormone receptor beta (THR-β) agonist, given orally once daily. | Drug | Cohort 1, Cohort 1a, Cohort 2, Cohort 2a, Cohort 3, Cohort 3a, Cohort 4, Cohort 5 |
Primary outcome
To determine number of participants with treatment-related adverse events as assessed by CTCAE v6.0 of single dose and multiple doses of CG-0416 in healthy participants.
Time frame: up to 3 weeks
Number of Incidence and frequency of adverse events (AEs) / SAEs possibly or probably related to study drug.
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants
Time frame: up to 3 weeks
Concentration changes from baseline in clinical laboratory safety tests: thyroid hormones [TH] , thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4)], follicle-stimulating hormone (FSH), luteinizing hormone, estradiol, testosterone, and free testosterone.
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants.
Time frame: up to 3 weeks
Baseline and placebo-corrected QTcF (ΔΔQTcF).
8 secondary outcomes
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time frame: Up to 3 weeks
To assess pharmacodynamic (PD) parameters
Time frame: up to 3 weeks
To assess pharmacodynamic (PD) parameter insulin
Time frame: up to 3 weeks
To assess pharmacodynamic (PD) parameter sex hormone binding globulin (SHBG)
Time frame: up to 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Ryan, MD principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-0416 in people with Overweight and Obesity, run by HongKong Curegene Innovation Co., Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Ryan, MD (61-0385939801, p.ryan@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine number of participants with treatment-related adverse events as assessed by CTCAE v6.0 of single dose and multiple doses of CG-0416 in healthy participants. (time frame: up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.