Safety IssuesPhase 1NCT05408663
A Phase 1 Study of EXT608 in Healthy Adults
A Phase 1 study testing EXT608 in people with Safety Issues, run by Extend Biosciences Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- EXT608
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 13 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age.
- Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
- In general good medical health with no clinically significant or relevant abnormalities,
- A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than (<) 16 g/dl (females) or 17.4 g/dl (males) or, if out of this range, deemed not clinically significant by the Investigator.
- Total serum calcium (Se-Ca) within laboratory normal limits.
- Serum parathyroid hormone (PTH) concentration within normal laboratory limits.
Who cannot join
- Evidence of clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, or psychiatric disorder
- History of drug abuse
- Currently using any medication including over-the-counter (OTC), herbal or homeopathic preparations
- Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study
- History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a human immunodeficiency virus (HIV)
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 the upper limit of normal (ULN)
- Increased baseline risk for osteosarcoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
Read the detailed description
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EXT608 in healthy adult participants.
Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.
Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.
Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.
A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of Adverse Events (AEs) at the discretion of the Investigator
- Conditions
- Safety Issues
- Being tested
- EXT608, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXT608Drug
Also called test drug
EXT608 is an investigational drug administered via subcutaneous injection
PlaceboOther
matching placebo administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental- EXT608 | Experimental | Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection Receives: Drug: EXT608 |
| Placebo comparator | Placebo comparator | Up to 6 participants will receive matching placebo administered as a subcutaneous injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the Safety and Tolerability of EXT608
Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs)
Measured: Day 0 to Day 28
Characterize the Safety and Tolerability of EXT608
Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings
Measured: Day 0 - Day 28
Characterize the Safety and Tolerability of EXT608
Percentage of participants with injection or infusion site reactions - edema
Measured: Day 0 - Day 28
Secondary outcomes (3)
Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC)
Area under the curve
Measured: Day 0 to Day 7
Single Dose PK - Cmax
Maximum observed concentration
Measured: 0-24 hr
Single Dose PK - Tmax
Time to reach maximum observed plasma concentration
Measured: Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start21 Jul 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety IssuesStudies 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
- Single ascending dose with up to 6 sequential dose escalation cohorts. Participants will be randomized to either study intervention (EXT608) or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Extend Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- Laura Hales, PhD, Study director, Extend Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408663
- Sponsor's protocol ID
- EXT608-101
- Other IDs
- R44DK107231
- Status last verified
- Jan 2025
- First submitted
- 31 May 2022
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study
- ClinicalTrials.gov ID
- NCT05408663
- Acronym / sponsor ID
- EXT608-101
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Extend Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pharmaceutical Research Associates
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
Detailed description
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EXT608 in healthy adult participants.
Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.
Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.
Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.
A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of Adverse Events (AEs) at the discretion of the Investigator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single ascending dose with up to 6 sequential dose escalation cohorts. Participants will be randomized to either study intervention (EXT608) or placebo
| Arm | Type | Receives |
|---|---|---|
| Experimental- EXT608 | Experimental | Drug: EXT608Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection |
| Placebo comparator | Placebo comparator | Other: PlaceboUp to 6 participants will receive matching placebo administered as a subcutaneous injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female between 18 and 55 years of age.
- Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
- In general good medical health with no clinically significant or relevant abnormalities,
- A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than (<) 16 g/dl (females) or 17.4 g/dl (males) or, if out of this range, deemed not clinically significant by the Investigator.
- Total serum calcium (Se-Ca) within laboratory normal limits.
Key exclusion criteria (8 listed)
- Evidence of clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, or psychiatric disorder
- History of drug abuse
- Currently using any medication including over-the-counter (OTC), herbal or homeopathic preparations
- Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study
- History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years
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 |
|---|---|---|
| EXT608Also: test drugEXT608 is an investigational drug administered via subcutaneous injection | Drug | Experimental- EXT608 |
| Placebomatching placebo administered via subcutaneous injection | Other | Placebo comparator |
Primary outcome
Characterize the Safety and Tolerability of EXT608
Time frame: Day 0 to Day 28
Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs)
Characterize the Safety and Tolerability of EXT608
Time frame: Day 0 - Day 28
Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings
Characterize the Safety and Tolerability of EXT608
Time frame: Day 0 - Day 28
Percentage of participants with injection or infusion site reactions - edema
3 secondary outcomes
Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC)
Time frame: Day 0 to Day 7
Single Dose PK - Cmax
Time frame: 0-24 hr
Single Dose PK - Tmax
Time frame: Day 0 to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Laura Hales, PhD study director
Extend Biosciences
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 EXT608 in people with Safety Issues, run by Extend Biosciences Inc. at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 4 Feb 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the Safety and Tolerability of EXT608 (time frame: Day 0 to Day 28). 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 4 Feb 2025.