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Clinical trial

A Phase 1a Study of IMR-687 in Healthy Adult Volunteers

ID
Name
IMR-SCD-101
Description
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.
Trial arms
Trial start
2016-10-18
Estimated PCD
2017-07-08
Trial end
2017-07-08
Status
Completed
Phase
Early phase I
Treatment
IMR-687
1 of 6 possible single doses administered orally following overnight fast
Arms:
Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6
Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Arms:
Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6
Other names:
Microcrystalline cellulose
Size
66
Primary endpoint
Number of participants with treatment emergent adverse events and serious adverse events
5 Days
Number of participants with clinically significant changes from baseline in vital signs
Baseline to Day 5
Number of participants with clinically significant changes from baseline in physical examination
Baseline to Day 5
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Baseline to Day 5
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Baseline to Day 2
Use of concomitant medications and therapies, medication type and frequency
5 Days
Eligibility criteria
Inclusion Criteria: * Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse. Exclusion Criteria: * Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive. * Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers. * A significant history of cardiovascular disease. * On ECG, a QTcF \>450 ms or the presence of clinically significant abnormalities as determined by the Investigator. * Elevated blood pressure. * Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2023-03-08

1 organization

2 products

3 indications

Organization
Imara
Product
IMR-687
Indication
Sickle Cell Disease
Indication
Sickle Cell
Indication
Sickle Beta 0 Thalassemia
Product
Placebo