A Study of Single-dose ALXN2050 in Healthy Adults

NCT ID: NCT05047458

Last Updated: 2021-09-17

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-04-13

Brief Summary

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This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: 40 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo on Day 1.

Group Type EXPERIMENTAL

ALXN2050

Intervention Type DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type DRUG

PIC.

Cohort 2: 80 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo on Day 1.

Group Type EXPERIMENTAL

ALXN2050

Intervention Type DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type DRUG

PIC.

Cohort 3: 120 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo on Day 1.

Group Type EXPERIMENTAL

ALXN2050

Intervention Type DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type DRUG

PIC.

Interventions

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ALXN2050

Powder-in-capsule (PIC).

Intervention Type DRUG

Placebo

PIC.

Intervention Type DRUG

Other Intervention Names

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ACH-0145228 (formerly) ACH-5228

Eligibility Criteria

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Inclusion Criteria

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
* Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
* Female participant of nonchildbearing potential.
* Male participant agreed to abstinence or use of a highly effective form of contraception.

Exclusion Criteria

* Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Had any condition possibly affecting drug absorption.
* Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
* Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
* Had participated in a clinical study within 30 days prior to first study drug administration
* Had clinically significant laboratory abnormalities,
* Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
* Had a clinically significant history of drug allergy.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Site

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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ACTRN12617001521314

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1203-1371

Identifier Type: OTHER

Identifier Source: secondary_id

ACH228-001

Identifier Type: -

Identifier Source: org_study_id

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