Skip to main content
. 2021 Sep 17;12:729424. doi: 10.3389/fphar.2021.729424

TABLE 3.

Summary of adverse events.

Adverse event SAD/Adult SAD elderly (Part A) MAD
System organ class (SOC) Preferred term (PT) TRC150094 5-400 mg n (%) Placebo TRC150094 Placebo TRC150094 Placebo (N = 7) n (%)
5a mg (N = 6) 25b mg (N = 6) 50c mg (N = 6) 100a mg (N = 6) 200b mg (N = 6) 400c mg (N = 6) All (N = 36) (N = 12) n (%) 50 mg (N = 12) 150 mg (N = 12) (N = 8) n (%) 50 mg (N = 12) n (%) 150 mg (N = 9) n (%)
 
No. of subjects reporting at least one AEs post-treatment 0 1 (16.7) 2 (33.3) 1 (16.7) 2 (33.3) 1 (16.7) 7 (19.4) 1 (8.3) 3 (25.0) 0 0 0 1 (11.1) 1 (14.3)
Metabolism and Nutrition Decreased Appetite 0 0 0 0 1 (16.7) 1 (16.7) 2 (5.6) 1 (8.3) 0 0 0 0 0 0
Musculoskeletal and Connective Tissue Disorders Back Pain 0 0 0 0 0 1 (16.7) 1 (2.8) 1 (8.3) 1 (8.3) 0 0 0 0 0
Myalgia 0 0 1 (16.7) 0 0 0 1 (2.8) 0 0 0 0 0 0 0
Pain in Extremity 0 0 0 0 1 (16.7) 1 (16.7) 2 (5.6) 0 0 0 0 0 0 0
Nervous System Disorders Dizziness Postural 0 1 (16.7) 0 1 (16.7) 0 0 2 (5.6) 0 0 0 0 0 0 0
Headache 0 0 1 (16.7) 0 1 (16.7) 1 (16.7) 3 (8.3) 0 1 (8.3) 0 0 0 0 0
General disorders and administration site conditions Pyrexia 0 0 0 0 0 0 0 0 0 0 0 0 1 (11.1) 0
Respiratory, thoracic, and mediastinal disorders Cough 0 0 0 0 0 0 0 0 0 0 0 0 0 1 (14.3)

N=Number of subjects with non-missing values; n/% = Number/percentage of subjects with the given characteristics.

a

Cohort 1 received 2 dose levels, 5 and 100 mg, separated by a washout period of 7 days.

b

Cohort 2 received 2 dose levels, 25 and 200 mg, separated by a washout period of 7 days.

c

Cohort 3 received 2 dose levels, 50 and 400 mg, separated by a washout period of 7 days.

Abbreviation: SAD, single ascending dose; MAD, multiple ascending doses.