Ulcerative ColitisPhase 1NCT05088369
Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201
A Phase 1 study testing HM201 in people with Ulcerative Colitis and Crohn's Disease, run by Syneos Health at 1 site in Australia.
Trial summary
This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD \& MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- HM201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Nov 2021to 19 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male or non-childbearing potential female
- BMI ≥18.0 and ≤32.0 kg/m2
- Good health based on past medical history, medication use, vital signs and physical exam.
- Normal renal and hepatic function.
- Female partners of child bearing potential must agree to use contraception.
Who cannot join
- Clinically significant medical history.
- Significant drug allergy.
- Use of experimental drug within 3 months prior.
- Previously received HM201, AM and other derivatives.
- History of old myocardial infarction.
- Diagnosed with malignant tumor or history of treatment for malignant tumor.
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- History of drug or alcohol abuse.
- Use of omitted medicines or substance opposing objective of study.
- COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration.
- Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site.
- Daily consumption of more than 1L of caffeine/xanthine beverage which cannot be discontinued more than 24 hours prior to dosing of investigational product and/or ECG measurement.
- Regular use of nutraceuticals (e.g., St. John's wort, ginseng, ginkgo biloba, Chinese herbs, and melatonin) within 1 week before administration of investigational product.
- Donation of plasma or platelet or 200 mL of whole blood within 4 weeks or 400 mL whole blood within 3 months before administration of investigational product.
- Clinically relevant findings in ECG.
- Systolic blood pressure below 100 mmHg or above 140 mmHg at screening.
- Diastolic blood pressure above 90 mmHg at screening.
- Heart rate below 40 beats/min or above 100 beats/min at screening.
- Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1).
- Hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb) hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antigen and antibody at screening.
- Positive to syphilis.
- Positive to urine drug test.
- Positive alcohol breath test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults)
This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD \& MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
Read the detailed description
Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study.
MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects; 2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- HM201, Placebo
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM201Drug
Also called Pegylated human adrenomedullin
HM201 will be administered intravenously.
PlaceboDrug
Also called Matching Placebo
Placebo will be administered intravenously.
HM201Drug
Also called Pegylated human adrenomedullin
HM201 will be administered intravenously.
PlaceboDrug
Also called Matching Placebo
Placebo will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1 to 4: Participants receiving HM201 | Experimental | Each SAD cohort participant will be randomized to receive 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg); 0.12 mg/kg (20 nmol/kg). Receives: Drug: HM201 |
| SAD Cohorts 1 to 4: Participants Receiving Placebo | Placebo comparator | Each SAD cohort participant will be randomized to receive placebo. Receives: Drug: Placebo |
| MAD Cohorts 1 to 4: Participants Receiving HM201 | Experimental | Each MAD cohort participant will be randomized to receive a once a week dose of 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg), 0.12 mg/kg (20 nmol/kg) for 4 weeks. Receives: Drug: HM201 |
| MAD Cohorts 1 to 4: Participants Receiving Placebo | Placebo comparator | Each MAD cohort participant will be randomized to receive placebo once a week for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation.
Measured: Up to 15 days post last infusion for both SAD & MAD
Secondary outcomes (9)
Plasma concentrations of HM201
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 1
Area under the plasma concentration versus time curve (AUC)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 2
Peak Plasma Concentration (Cmax)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 3
Time of peak plasma concentration (Tmax)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 4
Concentration at the last planned timepoint prior to dosing (Ctrough)
Measured: MAD: Up to Day 36
Pharmacokinetic assessment 5
Mean residence time (MRT)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 6
Drug clearance (CL) \& Clearance at steady state (CLss)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 7
Volume of distribution at steady state (Vss) \& during terminal phase (VZ)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 8
Half life (T1/2)
Measured: SAD: Up to Day 15. MAD: Up to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start11 Nov 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Parallel groups
- Model description
- SAD \& MAD study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Himuka AM Pharma Corp.
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088369
- Sponsor's protocol ID
- HM201-AUS-001
- Status last verified
- Jan 2023
- First submitted
- 12 Oct 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults)
- ClinicalTrials.gov ID
- NCT05088369
- Acronym / sponsor ID
- HM201-AUS-001
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Himuka AM Pharma Corp.
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 21 Oct 2021 (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.
This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD \& MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
Detailed description
Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study.
MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects; 2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- SAD \& MAD study
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1 to 4: Participants receiving HM201 | Experimental | Drug: HM201Each SAD cohort participant will be randomized to receive 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg); 0.12 mg/kg (20 nmol/kg). |
| SAD Cohorts 1 to 4: Participants Receiving Placebo | Placebo comparator | Drug: PlaceboEach SAD cohort participant will be randomized to receive placebo. |
| MAD Cohorts 1 to 4: Participants Receiving HM201 | Experimental | Drug: HM201Each MAD cohort participant will be randomized to receive a once a week dose of 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg), 0.12 mg/kg (20 nmol/kg) for 4 weeks. |
| MAD Cohorts 1 to 4: Participants Receiving Placebo | Placebo comparator | Drug: PlaceboEach MAD cohort participant will be randomized to receive placebo once a week for 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or non-childbearing potential female
- BMI ≥18.0 and ≤32.0 kg/m2
- Good health based on past medical history, medication use, vital signs and physical exam.
- Normal renal and hepatic function.
- Female partners of child bearing potential must agree to use contraception.
Key exclusion criteria (22 listed)
- Clinically significant medical history.
- Significant drug allergy.
- Use of experimental drug within 3 months prior.
- Previously received HM201, AM and other derivatives.
- History of old myocardial infarction.
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 |
|---|---|---|
| HM201Also: Pegylated human adrenomedullinHM201 will be administered intravenously. | Drug | SAD Cohorts 1 to 4: Participants receiving HM201 |
| PlaceboAlso: Matching PlaceboPlacebo will be administered intravenously. | Drug | SAD Cohorts 1 to 4: Participants Receiving Placebo |
| HM201Also: Pegylated human adrenomedullinHM201 will be administered intravenously. | Drug | MAD Cohorts 1 to 4: Participants Receiving HM201 |
| PlaceboAlso: Matching PlaceboPlacebo will be administered intravenously. | Drug | MAD Cohorts 1 to 4: Participants Receiving Placebo |
Primary outcome
Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation.
Time frame: Up to 15 days post last infusion for both SAD & MAD
9 secondary outcomes
Plasma concentrations of HM201
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 1
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 2
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 3
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 4
Time frame: MAD: Up to Day 36
Pharmacokinetic assessment 5
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 6
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 7
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 8
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
Kristi McLendon, 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 HM201 in people with Ulcerative Colitis and Crohn's Disease, run by Syneos Health 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 5 inclusion and 22 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 1 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation. (time frame: Up to 15 days post last infusion for both SAD & MAD). 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 1 Feb 2023.