Table 2.

AEs reported in healthy volunteers (MAD phase)

System organ class (%) Preferred term (%)	Placebo (n = 25)	15 mg Q1W (n = 6)	45 mg Q1W (n = 12)	90 mg Q1W (n = 12)	180 mg Q1W (n = 14)	45 mg Q2W (n = 12)	Any taldefgrobep alfa (n = 72)*	All (N = 97)*
Total subjects with AE	11 (44.0)	1 (16.7)	9 (75.0)	6 (50.0)	10 (71.4)	5 (41.7)	43 (59.7)	54 (55.7)
General disorders and administration-site conditions	3 (12.0)	0	5 (41.7)	4 (33.3)	5 (35.7)	1 (8.3)	19 (26.4)	22 (22.7)
Injection-site erythema	0	0	4 (33.3)	3 (25.0)	4 (28.6)	0	12 (16.7)	12 (12.4)
Injection-site bruising	1 (4.0)	0	0	2 (16.7)	2 (14.3)	0	4 (5.6)	5 (5.2)
Injection-site reaction	0	0	0	1 (8.3)	2 (14.3)	0	4 (5.6)	4 (4.1)
Injection-site hemorrhage	1 (4.0)	0	0	2 (16.7)	0	0	2 (2.8)	3 (3.1)
Injection-site papule	0	0	0	0	0	1 (8.3)	2 (2.8)	2 (2.1)
Injection-site rash	0	0	2 (16.7)	0	0	0	2 (2.8)	2 (2.1)
Chest pain	0	0	0	0	0	1 (8.3)	1 (1.4)	1 (1.0)
Fatigue	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Injection-site pruritus	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Skin and subcutaneous tissue disorders	6 (24.0)	0	5 (41.7)	3 (25.0)	3 (21.4)	0	15 (20.8)	21 (21.6)
Rash	1 (4.0)	0	3 (25.0)	2 (16.7)	0	0	8 (11.1)	9 (9.3)
Ecchymosis	0	0	0	1 (8.3)	1 (7.1)	0	3 (4.2)	3 (3.1)
Acne	2 (8.0)	0	0	0	0	0	0	2 (2.1)
Erythema	0	0	0	0	2 (14.3)	0	2 (2.8)	2 (2.1)
Rash maculopapular	1 (4.0)	0	1 (8.3)	0	0	0	1 (1.4)	2 (2.1)
Dermatitis	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Dry skin	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Papule	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Scab	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Skin lesion	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Infections and infestations	1 (4.0)	0	4 (33.3)	1 (8.3)	3 (21.4)	2 (16.7)	14 (19.4)	15 (15.5)
Upper respiratory tract infection	1 (4.0)	0	3 (25.0)	1 (8.3)	2 (14.3)	1 (8.3)	10 (13.9)	11 (11.3)
Gastroenteritis	0	0	0	0	0	1 (8.3)	1 (1.4)	1 (1.0)
Otitis media	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Sinusitis bacterial	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Viral infection	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Gastrointestinal disorders	1 (4.0)	1 (16.7)	1 (8.3)	2 (16.7)	2 (14.3)	1 (8.3)	9 (12.5)	10 (10.3)
Abdominal discomfort	1 (4.0)	0	0	1 (8.3)	0	0	2 (2.8)	3 (3.1)
Abdominal pain	0	0	1 (8.3)	0	0	1 (8.3)	2 (2.8)	2 (2.1)
Abdominal distension	0	0	0	1 (8.3)	0	0	1 (1.4)	1 (1.0)
Abdominal tenderness	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Chapped lips	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Diarrhea	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Lip dry	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Vomiting	0	1 (16.7)	0	0	0	0	1 (1.4)	1 (1.0)
Nervous system disorders	2 (8.0)	0	0	0	5 (35.7)	1 (8.3)	7 (9.7)	9 (9.3)
Headache	2 (8.0)	0	0	0	2 (14.3)	0	2 (2.8)	4 (4.1)
Dizziness	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Paresthesia	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Presyncope	0	0	0	0	0	1 (8.3)	1 (1.4)	1 (1.0)
Sensory disturbance	0	0	0	0	1 (7.1)	0	1 (1.4)	1 (1.0)
Somnolence	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Injury, poisoning, and procedural complications	3 (12.0)	0	2 (16.7)	1 (8.3)	0	0	5 (6.9)	8 (8.2)
Contusion	2 (8.0)	0	1 (8.3)	0	0	0	3 (4.2)	5 (5.2)
Arthropod bite	1 (4.0)	0	0	1 (8.3)	0	0	1 (1.4)	2 (2.1)
Eye injury	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Musculoskeletal and connective tissue disorders	0	0	1 (8.3)	3 (25.0)	2 (14.3)	1 (8.3)	8 (11.1)	8 (8.2)
Muscle spasms	0	0	0	1 (8.3)	2 (14.3)	0	3 (4.2)	3 (3.1)
Arthralgia	0	0	1 (8.3)	1 (8.3)	0	0	2 (2.8)	2 (2.1)
Back pain	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Myalgia	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Neck pain	0	0	0	0	0	1 (8.3)	1 (1.4)	1 (1.0)
Pain in extremity	0	0	0	1 (8.3)	0	0	1 (1.4)	1 (1.0)
Vascular disorders	0	0	1 (8.3)	0	0	0	2 (2.8)	2 (2.1)
Hematoma	0	0	0	0	0	0	1 (1.4)	1 (1.0)
Phlebitis	0	0	1 (8.3)	0	0	0	1 (1.4)	1 (1.0)
Eye disorders	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Blurred vision	1 (4.0)	0	0	0	0	0	0	1 (1.0)
Metabolism and nutrition disorders	0	0	0	1 (8.3)	0	0	1 (1.4)	1 (1.0)
Decreased appetite	0	0	0	1 (8.3)	0	0	1 (1.4)	1 (1.0)

AE adverse event, MAD multiple ascending dose, Q1W once-weekly dosing, Q2W once every 2 weeks dosing

*The totals include information from the Japanese 45 mg Q1W (n = 9) and 180 mg Q1W (n = 7) cohorts; values for the Japanese cohorts are not reported separately