Healthy MalePhase 1NCT04828265
Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
A Phase 1 study testing Aldafermin in people with Healthy Male, run by NGM Biopharmaceuticals, Inc at 1 site in United States.
Trial summary
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male
- What is being tested?
- Aldafermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 6 Jul 2021
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects between 18 and 65 years, inclusive, of age who are able to comprehend and willing to sign an informed consent form (ICF).
- Body mass index (BMI) range 18-35 kg/m2 (inclusive) at screening.
- Healthy subjects with no clinically significant medical history or findings on screening evaluation.
- Clinical laboratory evaluations (e.g., fasted chemistry, complete blood count, urinalysis) within the reference range for the test laboratory at screening, unless deemed not clinically significant by the investigator.
- Subjects with a female partner of childbearing potential must agree to consistent and adequate birth control.
Who cannot join
- Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of screening.
- Clinically significant medical history or clinical manifestation of any significant metabolic, allergic, hepatic, renal, hematological, pulmonary, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator).
- History of malignancy, except resected, localized basal cell carcinoma, and squamous cell carcinoma.
- Abnormal, clinically significant electrocardiogram findings, in the opinion of the investigator.
- Abnormal, clinically significant liver function laboratory test results at screening as determined by the investigator.
- Calculated creatinine clearance (Cockcroft-Gault) < 90 mL/min at screening.
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- Positive for hepatitis B surface antigen (HbsAg), human immunodeficiency antibodies (antiHIV), or hepatitis C virus antibodies (antiHCV) plus HCV-RNA. Subjects who are antiHCV positive, but HCV-RNA negative (secondary to treatment or viral clearance) are eligible with at least a 1-year period since documented sustained viral response at Week 12 post-treatment.
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry.
- Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to complete and/or participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
NGM Clinical Study Site 112
Cypress, California, 90630
About this study
Official title: A Phase 1, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Aldafermin in Healthy Adult Male Japanese and Non-Japanese Subjects
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
- Conditions
- Healthy Male
- Being tested
- Aldafermin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldaferminBiological
Also called NGM282
Single dose of aldafermin
| Study group | Role | What they receive |
|---|---|---|
| Aldafermin 0.3mg | Experimental | Subcutaneous injection of a single dose of aldafermin 0.3mg in healthy adult male Japanese or non-Japanese subjects Receives: Biological: Aldafermin |
| Aldafermin 1mg | Experimental | Subcutaneous injection of a single dose of aldafermin 1mg in healthy adult male Japanese or non-Japanese subjects Receives: Biological: Aldafermin |
| Aldafermin 3mg | Experimental | Subcutaneous injection of a single dose of aldafermin 3mg in healthy adult male Japanese or non-Japanese subjects Receives: Biological: Aldafermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of a single dose aldafermin
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Measured: 4 days
Area under the concentration-time curve of a single dose aldafermin
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity)
Measured: 4 days
Time to maximum concentration (Tmax) of a single dose aldafermin
Time to maximum concentration (Tmax)
Measured: 4 days
Apparent terminal elimination half-life (T1/2) of a single dose aldafermin
Apparent terminal elimination half-life (T1/2)
Measured: 4 days
Frequency of adverse events
Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Measured: 10 days
Type of adverse events
Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Measured: 10 days
Secondary outcomes (2)
Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
Absolute change from baseline
Measured: 6 and 24 hours post dose
Percent change of C4
Percent change from baseline
Measured: 6 and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start13 Apr 2021
- Primary completion6 Jul 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MaleStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NGM Study Director, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828265
- Sponsor's protocol ID
- 282-HV-105
- Status last verified
- Dec 2021
- First submitted
- 26 Mar 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Aldafermin in Healthy Adult Male Japanese and Non-Japanese Subjects
- ClinicalTrials.gov ID
- NCT04828265
- Acronym / sponsor ID
- 282-HV-105
- Conditions
- Healthy Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 2 Apr 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 is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aldafermin 0.3mg | Experimental | Biological: AldaferminSubcutaneous injection of a single dose of aldafermin 0.3mg in healthy adult male Japanese or non-Japanese subjects |
| Aldafermin 1mg | Experimental | Biological: AldaferminSubcutaneous injection of a single dose of aldafermin 1mg in healthy adult male Japanese or non-Japanese subjects |
| Aldafermin 3mg | Experimental | Biological: AldaferminSubcutaneous injection of a single dose of aldafermin 3mg in healthy adult male Japanese or non-Japanese subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subjects between 18 and 65 years, inclusive, of age who are able to comprehend and willing to sign an informed consent form (ICF).
- Body mass index (BMI) range 18-35 kg/m2 (inclusive) at screening.
- Healthy subjects with no clinically significant medical history or findings on screening evaluation.
- Clinical laboratory evaluations (e.g., fasted chemistry, complete blood count, urinalysis) within the reference range for the test laboratory at screening, unless deemed not clinically significant by the investigator.
- Subjects with a female partner of childbearing potential must agree to consistent and adequate birth control.
Key exclusion criteria (9 listed)
- Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of screening.
- Clinically significant medical history or clinical manifestation of any significant metabolic, allergic, hepatic, renal, hematological, pulmonary, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator).
- History of malignancy, except resected, localized basal cell carcinoma, and squamous cell carcinoma.
- Abnormal, clinically significant electrocardiogram findings, in the opinion of the investigator.
- Abnormal, clinically significant liver function laboratory test results at screening as determined by the investigator.
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 |
|---|---|---|
| AldaferminAlso: NGM282Single dose of aldafermin | Biological | Aldafermin 0.3mg, Aldafermin 1mg, Aldafermin 3mg |
Primary outcome
Maximum observed plasma concentration (Cmax) of a single dose aldafermin
Time frame: 4 days
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Area under the concentration-time curve of a single dose aldafermin
Time frame: 4 days
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity)
Time to maximum concentration (Tmax) of a single dose aldafermin
Time frame: 4 days
Time to maximum concentration (Tmax)
Apparent terminal elimination half-life (T1/2) of a single dose aldafermin
Time frame: 4 days
Apparent terminal elimination half-life (T1/2)
Frequency of adverse events
Time frame: 10 days
Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Type of adverse events
Time frame: 10 days
Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
2 secondary outcomes
Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
Time frame: 6 and 24 hours post dose
Percent change of C4
Time frame: 6 and 24 hours post dose
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 31 Jan 2022.
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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.
NGM Study Director study director
NGM Biopharmaceuticals, Inc
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 Aldafermin in people with Healthy Male, run by NGM Biopharmaceuticals, 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 5 inclusion and 9 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 31 Jan 2022. 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. 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?
Maximum observed plasma concentration (Cmax) of a single dose aldafermin (time frame: 4 days). The study lists 6 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 31 Jan 2022.