Phase 1 Safety Study of ALRN-5281 in Healthy Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Growth Hormone Deficiency	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	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

U.S. FDA Resources

Further study details as provided by Aileron Therapeutics:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum IGF-1 [ Time Frame: Predose, Day 1-Day 28 ] [ Designated as safety issue: No ]
Serum GH [ Time Frame: Predose, Day 1-Day 28 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Estimated Enrollment:	48
Study Start Date:	January 2013
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775358

Locations

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

Sponsors and Collaborators

Aileron Therapeutics

Investigators

Principal Investigator:	Bradley D Vince, D.O.	Vince and Associates
Study Director:	Hubert C Chen, M.D.	Aileron Therapeutics

More Information

No publications provided

Responsible Party:	Aileron Therapeutics
ClinicalTrials.gov Identifier:	NCT01775358 History of Changes
Other Study ID Numbers:	ALRN-100-01
Study First Received:	January 17, 2013
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine

Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013