Clinical Trials/NCT06435507

NCT06435507

Completed

Phase 1

Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers

Innovative Molecules GmbH1 site in 1 country18 target enrollmentApril 25, 2023

ConditionsHerpes Simplex Virus

InterventionsIM-250 (50 mg)IM-250 (100 mg)IM-250 (200 mg)IM-250 (400 mg)

DrugsIM-250 (50 mg)IM-250 (100 mg)IM-250 (200 mg)IM-250 (400 mg)

Overview

Phase: Phase 1
Intervention: IM-250 (50 mg)
Conditions: Herpes Simplex Virus
Sponsor: Innovative Molecules GmbH
Enrollment: 18
Locations: 1
Primary Endpoint: Occurrence (number) of dose-limiting toxicities (DLT)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up.

Twenty-four participants are planned to be enrolled in the trial. Each cohort may be expanded by up to 6 additional volunteers, resulting in a maximum of 48 participants possibly enrolled in the trial.

Ninety-six volunteers may need to be screened to include 48 volunteers.

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

May 28, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Innovative Molecules GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent Form (ICF),
•Age 18-50 y inclusive at the time of consent,
•An understanding, ability, and willingness to fully comply with study interventions and restrictions,
•Males who are willing to use a condom for contraception during the treatment and for 60 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse; females who are willing to use a highly effective method for contraception during the treatment and for 90 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse, or women not of child-bearing potential (WNOCBP).
•Satisfactory medical assessment without clinically significant or relevant abnormalities as determined by medical history, physical examination (PE), clinical (vital signs including normal heart rate \[50-90 bpm\]), laboratory (hematology, biochemistry, urinalysis), and electrocardiographic (ECG) evaluation (corrected QTc interval within normal range). First degree AV blocks may be acceptable, if the pulse rate complies with the inclusion criteria.
•Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related interventions.

Exclusion Criteria

•Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IMP or study interventions.
•Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to inhibit drug-metabolizing enzymes or transport enzymes within a period of less than 5 times the respective elimination t1/2 with regard to the expected date of IMP administration (except iodine, hormone replacement therapy, hormonal contraception, and levothyroxine).
•Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to induce drug-metabolizing enzymes or transport enzymes within a period of 14 d with regard to the expected date of IMP administration.
•A positive result in testing for illegal drugs at screening and enrollment.
•Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
•Consumption of alcohol within 24 h prior to Day 1 and until End of Study (EOS).
•Clinically relevant abnormalities regarding ECG conduction (AV block), hematocrit, hemoglobin (Hb), platelets, or leucocytes. A Hb value \> 12 g / dl (males) or \> 11 g / dl (females) is acceptable.
•Abnormal renal function as defined by estimated creatinine clearance: \< 90 ml / min (Cockcroft-Gault equation).
•Alanine aminotransferase (ALT) \> ULN x 1.1; aspartate aminotransferase (AST) \> ULN x 1.
•Thyroid-stimulating hormone (TSH) not within normal limits. If thyroid hormones are supplemented, reduced TSH values are acceptable, if free thyroxine (T4) and free triiodothyronine (T3), are within the normal range.

Arms & Interventions

Cohort 1

6 participants

Intervention: IM-250 (50 mg)

Cohort 2

6 participants

Intervention: IM-250 (100 mg)

Cohort 3

6 participants

Intervention: IM-250 (200 mg)

Cohort 4

6 participants

Intervention: IM-250 (400 mg)

Outcomes

Primary Outcomes

Occurrence (number) of dose-limiting toxicities (DLT)

Time Frame: within 28 days after exposure

* Serious adverse reaction (i.e., a serious adverse event (SAE) considered at least possibly related to IMP administration) * Severe (CTCAE grade III) non-serious adverse reactions (i.e., severe non-serious adverse event (AE) considered as, at least, possibly related to IMP administration) lasting more than 72 h

Secondary Outcomes

PK: The area under the plasma concentration-time curve extrapolated to infinity (AUC∞)(56 days)
PK: Maximum plasma concentration (Cmax)(8 days)
PK: Concentration at 24 h (C24h), 5 d (C5d), and 8 d (C8d)(24 hours, 5 days and 8 days)