Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
2. 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.
3. Ability to provide written informed consent and complying with all study requirements and restrictions.
4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion Criteria:

1. 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
2. Previous treatment with any GH Releasing Hormone (GHRH) analog.
3. Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
4. History of cancer within the past five years (excluding non-melanoma skin cancer).
5. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
6. Subjects with a body weight > 120 kg.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aileron Therapeutics, Inc.
• Investigators: Principal Investigator: Bradley D Vince, D.O., Vince and Associates; Study Director: Hubert C Chen, M.D., Aileron Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: ALRN-100-01