Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: ALRN-5281 0.015 mg/kg
* Drug: ALRN-5281 0.05 mg/kg
* Drug: ALRN-5281 0.15 mg/kg
* Drug: Placebo 0.015 mg/kg
* Drug: Placebo 0.05mg/kg
* Drug: Placebo 0.15mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALRN-5281 0.015 mg/kg<br>Dosage-0.015 mg/kg | Drug: ALRN-5281 0.015 mg/kg<br> <br> |
| Experimental: ALRN-5281 0.05 mg/kg<br>Dosage- 0.05 mg/kg | Drug: ALRN-5281 0.05 mg/kg<br> <br> |
| Experimental: ALRN-5281 0.15 mg/kg<br>Dosage- 0.15 mg/kg | Drug: ALRN-5281 0.15 mg/kg<br> <br> |
| Placebo Comparator: Placebo 0.015 mg/kg<br>Dosage- 0.015 mg/kg | Drug: Placebo 0.015 mg/kg<br> <br> |
| Placebo Comparator: Placebo 0.05 mg/kg<br>Dosage- 0.05 mg/kg | Drug: Placebo 0.05mg/kg<br> <br> |
| Placebo Comparator: Placebo 0.15 mg/kg<br>Dosage - 0.15 mg/kg | Drug: Placebo 0.15mg/kg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IGF-1 |  | Predose, Day 1-Day 28 | 
| Serum GH |  | Predose, Day 1-Day 28 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281 |  | 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 |  | 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) | Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14 |