Trial Outcomes & Findings for Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults (NCT NCT03408899)

Last Updated: 2023-04-14

Results Overview

AEs are defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \[Dated November 2007\], Male Genital \[Dated November 2007\] and Rectal \[Clarification Dated May 2012\] Grading Tables for Use in Microbicide Studies).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Results posted on

2023-04-14

Participant Flow

One participant terminated early due to "Lost to follow-up". One additional participant enrolled as replacement. Thus a total of 13 participants enrolled in the study.

Participant milestones

Participant milestones
Measure	All Enrolled Participants All enrolled participants will receive PC-1005 Gel in 4mL, 16mL, and 32mL dose.
PC-1005 Gel: 4 mL Dose STARTED	13
PC-1005 Gel: 4 mL Dose COMPLETED	12
PC-1005 Gel: 4 mL Dose NOT COMPLETED	1
PC-1005 Gel: 16 mL Dose STARTED	12
PC-1005 Gel: 16 mL Dose COMPLETED	12
PC-1005 Gel: 16 mL Dose NOT COMPLETED	0
PC-1005 Gel: 32 mL Dose STARTED	12
PC-1005 Gel: 32 mL Dose COMPLETED	12
PC-1005 Gel: 32 mL Dose NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Participants All enrolled participants will receive PC-1005 Gel in 4mL, 16mL, and 32mL dose.
PC-1005 Gel: 4 mL Dose Lost to Follow-up	1

Baseline Characteristics

Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PC-1005 n=13 Participants All participants will receive 3 single escalating doses of PC-1005 gel during Visits 3, 5, and 7, with a 2-to-6-week washout period between dosing visits. Each participant will be on study for approximately 3 to 5 months. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.1 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Height	171.0 cm n=5 Participants
Weight	94.3 kg n=5 Participants
BMI	32.1 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Outcome measures

Outcome measures
Measure	4 mL n=13 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=12 Participants All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=12 Participants All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Frequency of Grade 2 or Higher Adverse Events (AEs)	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Population: Participants are randomly assigned 1:1:1 to provide samples of rectal fluid 48 hours after one of the three dose administrations. One participant missed 2 hour postdosing plasma sample collection at 4mL dosing visit. One participant missed 1 hour postdosing plasma sample collection at 16mL dosing visit. One participant missed 24 hour postdosing plasma sample collection at 32mL dosing visit.

Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points

Outcome measures

Outcome measures
Measure	4 mL n=13 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=12 Participants All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=12 Participants All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
MIV-150 Concentrations in Plasma Predosing	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Plasma 1 hour postdosing	74.0 pg/mL Interval 52.0 to 86.0	164.0 pg/mL Interval 87.0 to 187.0	158.5 pg/mL Interval 110.0 to 267.5
MIV-150 Concentrations in Plasma 2 hours postdosing	66.5 pg/mL Interval 45.0 to 83.5	183.5 pg/mL Interval 162.0 to 211.0	171.0 pg/mL Interval 98.0 to 316.0
MIV-150 Concentrations in Plasma 3 hours postdosing	37.0 pg/mL Interval 23.0 to 54.0	134.0 pg/mL Interval 84.0 to 191.5	143.0 pg/mL Interval 66.0 to 172.5
MIV-150 Concentrations in Plasma 4 hours postdosing	24.0 pg/mL Interval 13.0 to 48.0	86.5 pg/mL Interval 63.0 to 143.5	105.0 pg/mL Interval 40.0 to 138.5
MIV-150 Concentrations in Plasma 5-6 hours postdosing	13.0 pg/mL Interval 11.0 to 28.0	57.0 pg/mL Interval 42.5 to 88.0	63.5 pg/mL Interval 25.0 to 121.0
MIV-150 Concentrations in Plasma 24 hours postdosing	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 22.0
MIV-150 Concentrations in Plasma 48 hours postdosing	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 0.0	0 pg/mL Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Population: Participants are randomized 1:1:1:1 to provide samples of rectal fluid in one of the following time periods after dose administration : 0.5-1 hour; 1.5-3 hours; 3.5-5 hours, or 24 hours. Participants are randomly assigned 1:1:1 to provide samples of rectal fluid 48 hours after one of the three dose administrations.

Outcome measures

Outcome measures
Measure	4 mL n=13 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=12 Participants All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=12 Participants All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
MIV-150 Concentrations in Rectal Fluid 0.5-1 hour postdosing	122.0 ng/mL Interval 13.2 to 11464.0	135.0 ng/mL Interval 20.2 to 3691.0	104.0 ng/mL Interval 72.8 to 7854.0
MIV-150 Concentrations in Rectal Fluid 1.5-3 hour postdosing	19.3 ng/mL Interval 14.1 to 41.9	23.2 ng/mL Interval 10.8 to 420.0	4582.0 ng/mL Interval 116.0 to 7272.0
MIV-150 Concentrations in Rectal Fluid 3.5-5 hour postdosing	19.6 ng/mL Interval 7.8 to 66.7	14.9 ng/mL Interval 3.1 to 37.0	39.7 ng/mL Interval 4.8 to 419.0
MIV-150 Concentrations in Rectal Fluid 24 hour postdosing	0 ng/mL Interval 0.0 to 0.0	5.9 ng/mL Interval 2.5 to 6.8	0 ng/mL Interval 0.0 to 131.0
MIV-150 Concentrations in Rectal Fluid 48 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 16.9	0 ng/mL Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Population: Three participants are randomized to provide rectal tissue sample in one of the following time periods after dose administration : 0.5-1 hour; 1.5-3 hours; 3.5-5 hours, or 24 hours. Four participants are randomized to provide rectal tissue sample 48 hours after each of the three dose administrations. Two participants had late sample at 4mL dose.

Outcome measures

Outcome measures
Measure	4 mL n=13 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=12 Participants All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=12 Participants All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates 0.5-1 hour postdosing	1.4 ng/mL Interval 0.8 to 1.9	46.0 ng/mL Interval 30.7 to 831.0	79.7 ng/mL Interval 11.9 to 116.0
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates 1.5-3 hour postdosing	0 ng/mL Interval 0.0 to 3.6	12.7 ng/mL Interval 4.8 to 313.0	35.8 ng/mL Interval 2.5 to 186.0
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates 3.5-5 hour postdosing	0 ng/mL Interval 0.0 to 0.9	4.8 ng/mL Interval 0.0 to 6.5	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates 24 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates 48 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Through study completion, approximately 3-5 months for each participant

Response for "Overall, how easy or difficult was it to use the gel when applied by clinic staff?" at exit self-interview questionnaire.

Outcome measures

Outcome measures
Measure	4 mL n=12 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Participant Self-report Gel Acceptability - Ease of Use Very difficult	0 Participants	—	—
Participant Self-report Gel Acceptability - Ease of Use Difficult	0 Participants	—	—
Participant Self-report Gel Acceptability - Ease of Use Easy	3 Participants	—	—
Participant Self-report Gel Acceptability - Ease of Use Very Easy	9 Participants	—	—

SECONDARY outcome

Timeframe: Through study completion, approximately 3-5 months for each participant

Population: All participants who completed the exit self-interview questionnaire

Response for "Overall, how did it feel to have the gel inside you?" at exit self-interview questionnaire.

Outcome measures

Outcome measures
Measure	4 mL n=12 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Participant Self-report Gel Acceptability - Feeling When Inserted Very comfortable	2 Participants	—	—
Participant Self-report Gel Acceptability - Feeling When Inserted Comfortable	8 Participants	—	—
Participant Self-report Gel Acceptability - Feeling When Inserted Uncomfortable	1 Participants	—	—
Participant Self-report Gel Acceptability - Feeling When Inserted Very uncomfortable	1 Participants	—	—

SECONDARY outcome

Timeframe: Through study completion, approximately 3-5 months for each participant

Population: All participants who completed the exit self-interview questionnaire

Responses for questions related to problem with gel use at exit self-interview questionnaire

Outcome measures

Outcome measures
Measure	4 mL n=12 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Participant Self-report Gel Acceptability - Problems With Gel Use Did you have any problems using this product? · Yes	0 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you have any problems using this product? · No	12 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any leakage after you used the product? · Yes	2 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any leakage after you used the product? · No	10 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any soiling of your underwear or linens from the gel? · Yes	0 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any soiling of your underwear or linens from the gel? · No	12 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any diarrhea after using the gel? · Yes	0 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any diarrhea after using the gel? · No	12 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any other stomach or abdominal problems after using the gel? · Yes	2 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any other stomach or abdominal problems after using the gel? · No	10 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any any dryness after using the product? · Yes	0 Participants	—	—
Participant Self-report Gel Acceptability - Problems With Gel Use Did you experience any any dryness after using the product? · No	12 Participants	—	—

SECONDARY outcome

Timeframe: Through study completion, approximately 3-5 months for each participant

Response for questions related to gel acceptability at exit self-interview questionnaire.

Outcome measures

Outcome measures
Measure	4 mL n=12 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 5	3 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 8	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 9	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 6	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 7	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 8	3 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 9	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 10 (Like very much)	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · Not Applicable	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 1 (Dislike very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 2	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 3	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 4	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 5	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 6	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 7	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 8	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 9	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · 10 (Like very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the smell of the gel? · Not Applicable	10 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 1 (Dislike very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 2	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 3	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 1 (Dislike very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 2	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 3	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability Overall, how much did you like the gel? · 4	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 4	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 5	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 6	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 7	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 8	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 9	3 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · 10 (Like very much)	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like the consistency of the gel? · Not Applicable	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 1 (Dislike very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 2	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 3	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 4	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 5	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 6	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 7	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 8	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 9	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · 10 (Like very much)	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum immediately after inserting it? · Not Applicable	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 1 (Dislike very much)	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 2	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 3	0 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 4	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 5	3 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 6	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 7	1 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · 10 (Like very much)	2 Participants	—	—
Participant Self-report Gel Acceptability - Gel Acceptability How much did you like how the gel felt inside your rectum 30 minutes after inserting it? · Not Applicable	0 Participants	—	—

SECONDARY outcome

Timeframe: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Outcome measures

Outcome measures
Measure	4 mL n=6 Participants All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=6 Participants All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=6 Participants All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
MIV-150 Concentrations in Vaginal Fluid 0.5-1 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Vaginal Fluid 1.5-3 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Vaginal Fluid 3.5-5 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Vaginal Fluid 24 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0
MIV-150 Concentrations in Vaginal Fluid 48 hour postdosing	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0	0 ng/mL Interval 0.0 to 0.0

Adverse Events

4 mL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

16 mL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

32 mL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	4 mL n=13 participants at risk All participants who received 4 mL of PC-1005 gel at Visits 3. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL dose administered rectally.	16 mL n=12 participants at risk All participants who received 16 mL of PC-1005 gel at Visits 5. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 16 mL dose administered rectally.	32 mL n=12 participants at risk All participants who received 32 mL of PC-1005 gel at Visits 7. PC-1005 gel: PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 32 mL dose administered rectally.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	8.3% 1/12 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Gastrointestinal disorders Haemorrhoids	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Investigations Blood creatinine increased	7.7% 1/13 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	8.3% 1/12 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	8.3% 1/12 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.
Ear and labyrinth disorders Vertigo	0.00% 0/13 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	8.3% 1/12 • Number of events 1 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.	0.00% 0/12 • From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.

Additional Information

Craig Hendrix, MD

Johns Hopkins University

Phone: 4109559707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place