Growth Hormone DeficiencyPhase 1NCT01775358
Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
A Phase 1 study testing ALRN-5281 0.015 mg/kg, ALRN-5281 0.05 mg/kg and ALRN-5281 0.15 mg/kg in people with Growth Hormone Deficiency, run by Aileron Therapeutics, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- ALRN-5281 0.015 mg/kg, ALRN-5281 0.05 mg/kg and ALRN-5281 0.15 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
- Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
- Ability to provide written informed consent and complying with all study requirements and restrictions.
- Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening
Who cannot join
- History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
- Previous treatment with any GH Releasing Hormone (GHRH) analog.
- Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- History of cancer within the past five years (excluding non-melanoma skin cancer).
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
- Subjects with a body weight > 120 kg.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research, LLC
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers
The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
- Conditions
- Growth Hormone Deficiency
- Being tested
- ALRN-5281 0.015 mg/kg, ALRN-5281 0.05 mg/kg, ALRN-5281 0.15 mg/kg, Placebo 0.015 mg/kg, Placebo 0.05mg/kg
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALRN-5281 0.015 mg/kgDrug
ALRN-5281 0.05 mg/kgDrug
ALRN-5281 0.15 mg/kgDrug
Placebo 0.015 mg/kgDrug
Placebo 0.05mg/kgDrug
Placebo 0.15mg/kgDrug
| Study group | Role | What they receive |
|---|---|---|
| ALRN-5281 0.015 mg/kg | Experimental | Dosage-0.015 mg/kg Receives: Drug: ALRN-5281 0.015 mg/kg |
| ALRN-5281 0.05 mg/kg | Experimental | Dosage- 0.05 mg/kg Receives: Drug: ALRN-5281 0.05 mg/kg |
| ALRN-5281 0.15 mg/kg | Experimental | Dosage- 0.15 mg/kg Receives: Drug: ALRN-5281 0.15 mg/kg |
| Placebo 0.015 mg/kg | Placebo comparator | Dosage- 0.015 mg/kg Receives: Drug: Placebo 0.015 mg/kg |
| Placebo 0.05 mg/kg | Placebo comparator | Dosage- 0.05 mg/kg Receives: Drug: Placebo 0.05mg/kg |
| Placebo 0.15 mg/kg | Placebo comparator | Dosage - 0.15 mg/kg Receives: Drug: Placebo 0.15mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 28 days
Secondary outcomes (5)
Serum IGF-1
Measured: Predose, Day 1-Day 28
Serum GH
Measured: Predose, Day 1-Day 28
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281
Measured: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Maximum plasma concentration (Cmax) of ALRN-5281
Measured: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aileron Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley D Vince, D.O., Principal investigator, Vince and AssociatesHubert C Chen, M.D., Study director, Aileron Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775358
- Sponsor's protocol ID
- ALRN-100-01
- Status last verified
- May 2013
- First submitted
- 17 Jan 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01775358
- Acronym / sponsor ID
- ALRN-100-01
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aileron Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jan 2013 (estimated)
- 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.
The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALRN-5281 0.015 mg/kg | Experimental | Drug: ALRN-5281 0.015 mg/kgDosage-0.015 mg/kg |
| ALRN-5281 0.05 mg/kg | Experimental | Drug: ALRN-5281 0.05 mg/kgDosage- 0.05 mg/kg |
| ALRN-5281 0.15 mg/kg | Experimental | Drug: ALRN-5281 0.15 mg/kgDosage- 0.15 mg/kg |
| Placebo 0.015 mg/kg | Placebo comparator | Drug: Placebo 0.015 mg/kgDosage- 0.015 mg/kg |
| Placebo 0.05 mg/kg | Placebo comparator | Drug: Placebo 0.05mg/kgDosage- 0.05 mg/kg |
| Placebo 0.15 mg/kg | Placebo comparator | Drug: Placebo 0.15mg/kgDosage - 0.15 mg/kg |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
- Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
- Ability to provide written informed consent and complying with all study requirements and restrictions.
- Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening
Key exclusion criteria (6 listed)
- History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
- Previous treatment with any GH Releasing Hormone (GHRH) analog.
- Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- History of cancer within the past five years (excluding non-melanoma skin cancer).
- History of alcohol or drug abuse or dependence within 12 months of 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 |
|---|---|---|
| ALRN-5281 0.015 mg/kg | Drug | ALRN-5281 0.015 mg/kg |
| ALRN-5281 0.05 mg/kg | Drug | ALRN-5281 0.05 mg/kg |
| ALRN-5281 0.15 mg/kg | Drug | ALRN-5281 0.15 mg/kg |
| Placebo 0.015 mg/kg | Drug | Placebo 0.015 mg/kg |
| Placebo 0.05mg/kg | Drug | Placebo 0.05 mg/kg |
| Placebo 0.15mg/kg | Drug | Placebo 0.15 mg/kg |
Primary outcome
Incidence of adverse events
Time frame: 28 days
5 secondary outcomes
Serum IGF-1
Time frame: Predose, Day 1-Day 28
Serum GH
Time frame: Predose, Day 1-Day 28
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281
Time frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Maximum plasma concentration (Cmax) of ALRN-5281
Time frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14
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 30 May 2013.
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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.
Bradley D Vince, D.O. principal investigator
Vince and Associates
Hubert C Chen, M.D. study director
Aileron Therapeutics, 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 ALRN-5281 0.015 mg/kg, ALRN-5281 0.05 mg/kg and ALRN-5281 0.15 mg/kg in people with Growth Hormone Deficiency, run by Aileron Therapeutics, 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 4 inclusion and 6 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 30 May 2013. 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?
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?
Incidence of adverse events (time frame: 28 days). 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 30 May 2013.