Safety & PK of Single Doses of MT1980

• Sponsor: Monument Therapeutics Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05429840
• Collaborator: ICON plc (Industry)
• Enrollment: 32
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat.

This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.

Condition or Disease	Intervention/Treatment	Phase
Neuroinflammatory Response	Drug: MT1980; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Part 1: Open Label Part 2: Blinded
• Primary Purpose: Prevention
• Official Title: A Two-part, Single Dose, Randomized, Single Blinded, Placebo Controlled, Phase I Study to Assess the Safety and Pharmacokinetics of Oral MT1980 in Healthy Volunteers When Dosed in the Fasted State
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 MT1980	Drug: MT1980; single dose
Placebo Comparator: Part 1 Placebo	Drug: Placebo; single dose
Experimental: Part 2 MT1980 Dose Level 1	Drug: MT1980; single dose
Experimental: Part 2 MT1980 Dose Level 2	Drug: MT1980; single dose
Placebo Comparator: Part 2 Placebo	Drug: Placebo; single dose

Outcome Measures

Primary Outcome Measures

1. Treatment-related adverse events [Day 1 to Day 11]

   Descriptive statistics comparing MT1980 & placebo following a single dose of study drug. Number of subjects, number of events and severity of events to be reported

Secondary Outcome Measures

1. Systemic bioavailability of MT1980 [72 hours post dose]

2. Level of MT1980 in CSF [up to 7 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers with good physical and mental health

• Body Mass Index 18 to 30 kg/m2

• Men & women of child-bearing potential must agree to use adequate contraception

• Willing & able to provide written informed consent and to communicate and participate in the study

Exclusion Criteria:

• Clinically significant abnormal biochemistry, haematology, urinalysis results

• Results of screening liver function or kidney function tests outside of normal ranges

• Heavy daily smoking or use of nicotine containing substances

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icon Early Development Services	Groningen		Netherlands

Sponsors and Collaborators

• Monument Therapeutics Limited
• ICON plc

Investigators

• Principal Investigator: Principal Investigator, Icon Early Development Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Monument Therapeutics Limited
• ClinicalTrials.gov Identifier: NCT05429840
• Other Study ID Numbers: PCD101; 2022-000252-11; MUT21622-21622X
• First Posted: Jun 23, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Monument Therapeutics Limited: pharmacokinetics; neuroinflammation

Study Results

No Results Posted as of Jun 23, 2022