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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775358
Other study ID # ALRN-100-01
Secondary ID
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


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
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