Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: MK-2060; Biological: Placebo

• Registration Number: NCT06843993
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

The key inclusion criteria include but are not limited to the following:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤28 kg/m^2.

Exclusion Criteria

The key exclusion criteria include but are not limited to the following:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer (malignancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Panel A: MK-2060 Dose 1	MK-2060	MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1.
Panel B: MK-2060 Dose 2	MK-2060	MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B.
Panel C: MK-2060 Dose 3	MK-2060	MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C.
Placebo	Placebo	Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of participants who experience one or more adverse events (AEs)	Up to 164 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study due to an AE	Up to 164 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who experience one or more AEs related to bleeding	Up to 164 days	A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding.

Secondary Outcome Measures

Name	Time	Method
Plasma concentration at 168 hours (C168hr) of MK-2060	At designated timepoints (up to 168 hours)	C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. Blood samples were collected at pre-specified time points to assess C168hr.
Plasma concentration at end of infusion (Ceoi) of MK-2060	Predose Day 1 and end of infusion	Ceoi is defined as the amount of MK-2060 in plasma following IV infusion administration of MK-2060. Blood samples were collected at pre-specified time points to assess Ceoi.
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060	At designated timepoints (up to 150 days)	AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. Blood samples were collected at pre-specified time points to assess AUC0-inf.
AUC from 0 to 168 hours (AUC0-168) of MK-2060	At designated timepoints (up to 168 hours)	AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. Blood samples were collected at pre-specified time points to assess AUC0-168.
Time to maximum observed plasma drug concentration (Tmax) of MK-2060	At designated timepoints (up to 150 days)	Tmax is defined as time to the maximum concentration of MK-2060 reached. Blood samples were collected at pre-specified time points to assess Tmax.
Terminal half-life of MK-2060	At designated timepoints (up to 150 days)	t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. Blood samples were collected at pre-specified time points to assess terminal half-life.
Clearance (CL) of MK-2060	At designated timepoints (up to 150 days)	CL is the volume of plasma from which MK-2060 is completely removed per unit time. Blood samples were collected at pre-specified time points to assess CL.
Volume of distribution (Vz) of MK-2060	At designated timepoints (up to 150 days)	Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz.
Change from baseline in activated partial thromboplastin time (aPTT)	Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)	Blood samples were collected at pre-specified time points to assess change from baseline in aPTT.
Anti-drug antibodies (ADA) positive incidence	At designated timepoints (up to 150 days)	Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies.
Factor XI (FXI) activity level	At designated timepoints (up to 150 days)	Blood samples were collected at pre-specified time points to assess FXI activity level.
Prothrombin time (PT)	At designated timepoints (up to 150 days)	Blood samples were collected at pre-specified time points to assess PT.

Trial Locations

Locations (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001); 🇨🇳 Shanghai, Shanghai, China