Study to evaluate the concentrations and safety/tolerability of IV DM199 when administered in a PVC bag

Phase 1

Completed

• Conditions: Adult healthy participants (Part A) and adults recently taking ACE inhibitors (Part B); Not Applicable

• Registration Number: ISRCTN54869523
• Lead Sponsor: DiaMedica Therapuetics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-17
• Study Completion: 2023-07-07
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. =18 years of age
2. Part A only: healthy participants with no clinically significant medical problems and taking no medications for a chronic medical condition (oral supplements and vitamins as well as oral contraception medications are allowed)
3. Part B only: non-healthy participants recently taking ACE inhibitor medications:
3.1. Non-healthy participants taking ACE inhibitor medications for chronic medical conditions including hypertension, diabetes, or mild congestive heart failure with the last dose of medication taken >24 hours prior to the start of the IV infusion
3.2. Participant is willing to forego taking prescribed ACE inhibitor medication through the duration of the study or at minimum do not restart ACE inhibitor until 24 hours after completion of the IV infusion (i.e., half-life of DM199 given IV is approximately 4 hours
and 24 hours is greater than 5 half-lives)
3.3. All other chronic medications may be allowed if taking stable doses for at least 3 months with no new recent medications, and with pre-approval from the Sponsor Medical Monitor
4. Weight between 50 and 130 kg
5. No history of alcohol or drug abuse (barbiturates, benzodiazepines, cocaine, methadone, amphetamines, methamphetamines, opiates, tetrahydrocannabinol [cannabis])
6. Non-smokers or light smokers (<5 cigarettes per day or approximately equivalent nicotine amount) by history and planned during the study; smoking includes tobacco and nicotine only vaping
7. No history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis
8. Willing and able to sign written, informed consent
9. Participant is willing and able to comply with the study protocol, in the PI's opinion

Exclusion Criteria

1. Participant has a positive drug test and/or a positive alcohol breath test
2. Any significant past or current cardiac, pulmonary, hepatic, renal or other medical condition which in the opinion of the investigator would make the participation of the participant in this study medically unsafe or compromise the accuracy of assessment of safety, and PK data of the study
3. Participants who have abnormal safety labs outside the local lab ranges will be excluded at the PI’s discretion based on his/her assessment of clinical significance (can be repeated once at Screening at the PI’s discretion)
4. Participants with a past medical history of malignancy except for basal cell or squamous cell carcinoma of the skin who have had curative surgical treatment and at least 6 months have elapsed since the procedure
5. A value below the specified range of 100 mmHg for SBP OR 60 mmHg for DBP at Screening (can be repeated once at Screening as per PI’s discretion)
6. History of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to Screening
7. Clinical or laboratory evidence of an active infection at the time of Screening
8. Known alpha 1-antitrypsin deficiency (a1-antitrypsin deficiency)
9. Serological evidence of HIV, HBsAg, or anti-HCV at Screening
10. Females who are pregnant or nursing
11. Females of childbearing potential (i.e., any woman who is not surgically sterile e.g., hysterectomy, bilateral oophorectomy or >1-year postmenopausal status confirmed by FSH levels as defined by established lab ranges) and all men who, if participating in heterosexual sexual activity that could lead to pregnancy are unable or unwilling to practice medically effective contraception during the study. They should agree to use two reliable methods of contraception (eg, double-barrier condom plus diaphragm, condom or diaphragm plus a stable dose of hormonal contraception) throughout the study period and until 1 month after receiving the study drug. Women of childbearing potential (WOCBP) will require compulsory pregnancy testing. A negative pregnancy test (urine) will be documented during Screening and on Day -1 respectively
12. Participation in any other drug study within 8 weeks or 5 half-lives of the study drug, whichever is longer
13. Unable or unwilling to comply with the protocol requirements for study visits and procedures
14. Participants who do not have good venous access for infusion of study drug or for blood sampling

Study & Design

• Study Type: Interventional
• Study Design: Not specified