A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants

NCT05751642

Healthy Participants

COMPLETED PHASE1

Study of ALXN1820 in Healthy Adult Participants

NCT04631562

Healthy

COMPLETED PHASE1

Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

NCT05501717

Healthy

ACTIVE_NOT_RECRUITING PHASE1

Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants

NCT05307978

Healthy

COMPLETED PHASE1

A Study of ALXN1830 in Healthy Adult Participants

NCT04730804

Healthy

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 2

Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 3

Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 4

Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 5

Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 6

Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Cohort 7

Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).

Group Type EXPERIMENTAL

ALXN1830

Intervention Type DRUG

ALXN1830 will be administered as SC infusion(s).

Placebo

Intervention Type DRUG

Placebo will be administered as SC infusion(s).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALXN1830

ALXN1830 will be administered as SC infusion(s).

Intervention Type DRUG

Placebo

Placebo will be administered as SC infusion(s).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Satisfactory medical assessment.
* Participants must have had vaccination against pneumococcus (Pneumovax 23 \[PPSV23\]) at least 28 days, and maximally 4 years prior to Day 1.
* Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
* Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m\^2, inclusive.
* Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.

Exclusion Criteria

* Current/recurrent diseases or relevant medical history.
* Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
* Participants who have prior exposure to ALXN1830.
* Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
* Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
* Presence of hepatitis B surface antigen (HBsAg) at Screening.
* Positive hepatitis C antibody test result at Screening.
* Positive human immunodeficiency virus (HIV) antibody test at Screening.
* Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes