Trial Outcomes & Findings for A Study of RGLS8429 in Healthy Volunteers (NCT NCT05429073)
NCT ID: NCT05429073
Last Updated: 2025-08-27
Results Overview
Incidence and severity of adverse events after administration of RGLS8429
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline to Day 29
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
RGLS8429, First Dose Level
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Second Dose Level
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Third Dose Level
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Fourth Dose Level
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
Matching Placebo
Eligible participants will receive subcutaneous injection of the placebo volume-matching RGLS8429 dose.
Placebo volume-matching RGLS8429 dose: solution for subcutaneous injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of RGLS8429 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
RGLS8429, First Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Second Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Third Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Fourth Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
Matching Placebo
n=8 Participants
Eligible participants will receive subcutaneous injection of the placebo volume-matching RGLS8429 dose.
Placebo volume-matching RGLS8429 dose: solution for subcutaneous injection
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
32 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 9.48 • n=93 Participants
|
33.8 Years
STANDARD_DEVIATION 6.68 • n=4 Participants
|
34.2 Years
STANDARD_DEVIATION 6.18 • n=27 Participants
|
38.2 Years
STANDARD_DEVIATION 9.28 • n=483 Participants
|
43.9 Years
STANDARD_DEVIATION 6.58 • n=36 Participants
|
37.7 Years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
26 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
8 participants
n=36 Participants
|
32 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: Safety Population: all subjects who received a dose of study drug; subjects were analyzed based on treatment received
Incidence and severity of adverse events after administration of RGLS8429
Outcome measures
| Measure |
RGLS8429, First Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Second Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Third Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Fourth Dose Level
n=6 Participants
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
Matching Placebo
n=8 Participants
Eligible participants will receive subcutaneous injection of the placebo volume-matching RGLS8429 dose.
Placebo volume-matching RGLS8429 dose: solution for subcutaneous injection
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events (AEs)
Number of subjects with Treatment-emergent adverse events leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Number of Subjects with Serious Adverse Events or deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events (AEs)
Number of subjects with at least one treatment-emergent adverse event
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
3 participants
|
|
Incidence of Adverse Events (AEs)
Number of subjects with Grade 3, 4 or 5 treatment-emergent adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Day 29Identify dose limiting toxicity and the maximum tolerated dose after RGLS8429 administration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 15Measure plasma elimination half-life after RGLS8429 administration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 15Measure plasma clearance after RGLS8429 administration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 15Measure area under the plasma concentration vs time curve after RGLS8429 administration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 24-hourMeasure the amount of RGLS8429 excreted in urine after RGLS8429 administration
Outcome measures
Outcome data not reported
Adverse Events
RGLS8429, First Dose Level
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RGLS8429, Second Dose Level
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RGLS8429, Third Dose Level
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RGLS8429, Fourth Dose Level
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RGLS8429, First Dose Level
n=6 participants at risk
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Second Dose Level
n=6 participants at risk
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Third Dose Level
n=6 participants at risk
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
RGLS8429, Fourth Dose Level
n=6 participants at risk
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429.
RGLS8429: solution for subcutaneous injection
|
Matching Placebo
n=8 participants at risk
Eligible participants will receive subcutaneous injection of the placebo volume-matching RGLS8429 dose.
Placebo volume-matching RGLS8429 dose: solution for subcutaneous injection
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
12.5%
1/8 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
General disorders
Medical device site reaction
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
25.0%
2/8 • Number of events 2 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
16.7%
1/6 • Number of events 1 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/6 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
0.00%
0/8 • All Adverse Events were collecting beginning with the start of study drug administration until the Day 29 End of Study Visit.
|
Additional Information
Kristen Gillotti, Senior Director Clinical Operations
Regulus Therapeutics
Phone: 203-313-8185
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place