A Study of IMR-687 in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-18

Study Completion Date

2017-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Sickle Cell Disease Sickle-Cell; Hb-SC Sickle Beta 0 Thalassemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Cohort 2

4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Cohort 3

4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Cohort 4

4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Cohort 5

4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Cohort 6

4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Group Type EXPERIMENTAL

IMR-687

Intervention Type DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral Capsule

Intervention Type DRUG

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Interventions

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IMR-687

1 of 6 possible single doses administered orally following overnight fast

Intervention Type DRUG

Placebo Oral Capsule

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Intervention Type DRUG

Other Intervention Names

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Microcrystalline cellulose

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes