MedDataX Logo

A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers

NCT ID: NCT05366634

Last Updated: 2024-05-08

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

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-12-28

Brief Summary

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

MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.

Related Clinical Trials

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

Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.

NCT00749333

Healthy Volunteer
COMPLETED PHASE1

A Phase 1 Study of S-4321

NCT06877611

Healthy Volunteer
RECRUITING PHASE1

A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

NCT02406989

Safety and PK in Healthy Volunteers
COMPLETED PHASE1

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants

NCT07281703

Healthy
NOT_YET_RECRUITING PHASE1

Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers

NCT04485481

Safety Issues
COMPLETED PHASE1

Detailed Description

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

Conditions

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

Healthy Volunteers

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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

Cohort 1

Single injection of MDK-703 (dose level 1) or matching placebo

Group Type EXPERIMENTAL

MDK-703 or Placebo

Intervention Type BIOLOGICAL

Injection

Cohort 2

Single injection of MDK-703 (dose level 2) or matching placebo

Group Type EXPERIMENTAL

MDK-703 or Placebo

Intervention Type BIOLOGICAL

Injection

Cohort 3

Single injection of MDK-703 (dose level 3) or matching placebo

Group Type EXPERIMENTAL

MDK-703 or Placebo

Intervention Type BIOLOGICAL

Injection

Interventions

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

MDK-703 or Placebo

Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

1\. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs.

Exclusion Criteria

1\. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medikine Australia Pty Ltd.

UNKNOWN

Sponsor Role collaborator

Medikine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medikine Clinical Site

Herston, Queensland, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDK-703-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
NCT00796965 COMPLETED PHASE1
Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers
NCT06780124 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
NCT02480296 COMPLETED PHASE1
AZD8683 Single Ascending Dose Study
NCT00979849 COMPLETED PHASE1
A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687
NCT01046357 COMPLETED PHASE1
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
NCT00844103 COMPLETED PHASE1
Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants
NCT06595706 COMPLETED PHASE1
Multiple Ascending Dose Study in Healthy Volunteers
NCT02404922 COMPLETED PHASE1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State.
NCT05662033 COMPLETED PHASE1
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers
NCT03792308 COMPLETED PHASE1
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
NCT00861718 COMPLETED PHASE1
A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects
NCT05653037 ACTIVE_NOT_RECRUITING PHASE1
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683
NCT01419600 COMPLETED PHASE1
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
NCT05274659 COMPLETED PHASE1
This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers
NCT06926218 NOT_YET_RECRUITING PHASE1
Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
NCT06402136 COMPLETED PHASE1
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers
NCT05397041 COMPLETED PHASE1
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
NCT06577337 RECRUITING PHASE1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants
NCT06311760 COMPLETED PHASE1
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants
NCT05107336 COMPLETED PHASE1
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants
NCT02859701 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
NCT05143905 COMPLETED PHASE1
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
NCT00687232 COMPLETED PHASE1
Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects
NCT00953888 COMPLETED PHASE1
MT1013 Clinical TRIAL In Healthy Subject
NCT04783090 COMPLETED PHASE1