Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775358
• Other study ID #: ALRN-100-01
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2013
• Last updated: May 29, 2013
• Start date: January 2013
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Aileron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• 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

• Placebo 0.15mg/kg

Locations

Country	Name	City	State
United States	Vince and Associates Clinical Research, LLC	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Aileron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		28 days	No
Secondary	Serum IGF-1		Predose, Day 1-Day 28	No
Secondary	Serum GH		Predose, Day 1-Day 28	No
Secondary	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	No
Secondary	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	No
Secondary	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	No